Overview

This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs). It will teach best practices to meet regulatory requirements and satisfy practical needs to obtain the best CMO.

Why should you Attend

Regulatory agencies require that companies carefully select suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated to the Contract Manufacturing Organization (CMO). CMO’s must be selected following a rigorous formalized procedure.

This webinar will describe a compliant program based on regulatory requirements and the author’s personal experience in qualifying over 40 CMO’s in the medical device industry.

Session Highlights

• CMO management principles

• Supplier quality categories

• Approved Vendor List (AVL)

• Phases of CMO selection from initial telephone inquiry to quality survey to qualification audit

• Planning a qualification audit-establishing evaluation team

• Conducting a qualification audit-key points to evaluate

• Decision factors for selecting a CMO-key practical points

• Distinctive technical competence

• Optimum CMO size

• Risk of educating future competitor

• Key points for the contract

• Change approval by both CMO and company

• Quality Agreement

• Dealing with uncooperative suppliers

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Who Will Benefit

Engineering personnel
QA personnel
Software developers
Project managers
Regulatory affairs professionals
Global contract manufacturing transfer teams
Quality Control personnel
Research & Development
Regulatory Affairs Professionals
Validation
Those that use contract manufacturing and contract testing facilities
Microbiology Professionals
Project Managers

Speaker Profile

Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems.

Wcs Seminars
Registration Details
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